DehydrationNCT05129358
Testing of an Electronic Patch During Mild Dehydration
A study testing Dehydration and Rehydration in people with Dehydration, run by Mode Sensors AS at 1 site in Norway.
Trial summary
The purpose of this study is to investigate the ability of a wearable bioimpedance sensor to detect mild dehydration in healthy volunteers following the administration of Furosemide. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Dehydration
- What is being tested?
- Dehydration and Rehydration
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteNorway
- Study dates
- 30 May 2022to 3 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI: 18-30
- Age: 18-60
- Willing to refrain from exercise for the duration of the study
- Willing to refrain from bathing, swimming and other physical activity causing considerable sweating/movement (e.g. cycling, mountain hiking, climbing)
Who cannot join
- Hypersensitivity to diuretics
- Diarrhea
- Hypotension or orthostatic hypotension
- Urinary retention
- Pregnancy or breast feeding
- Allergy to medical adhesive or gel
Show all 9Show fewer
- Any planned medical examination during the intervention period
- Pacemaker
- Use of medication with a significant impact on the body's fluid balance, such as diuretic
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Testing of an Electronic Patch During Dehydration in Healthy Volunteers
The purpose of this study is to investigate the ability of a wearable bioimpedance sensor to detect mild dehydration in healthy volunteers following the administration of Furosemide. In addition, the study will investigate changes in bioimpedance related to normal variation in tissue hydration (circadian changes, skin thickness, posture, and moderate activity). The study will also provide information on the durability of the sensor.
Read the detailed description
The subjects will use the patches for ten days. During the ten-day period, subjects are exposed to an intervention on day 2 or 3 while being monitored by health personnel:
- Subjects are given a diuretic (Furosemide) and monitored for two hours without any intake.
- The intervention is followed by intake of a rehydration solution (up to 1500 ml), containing glucose and electrolytes (Resorb Sport, Nestle S.A.).
- Conditions
- Dehydration
- Being tested
- Dehydration, Rehydration
- Keywords
- Dehydration, Rehydration
- Medical subject headings
- Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DehydrationDrug
Also called Dehydration from Furosemide
The subject is brought to mild dehydration (loss of approximately 1.5% of body weight) through intravenous injection of up to 40 ug Furosemide. The subject shall not ingest any fluid for the next 120 minutes.
RehydrationDietary supplement
Also called Rehydration by Resorb Sport
The subject is rehydrated by oral intake of 1.5 liters Resorb Sport (Nestlé). The subject is monitored for 60 minutes following intake.
| Study group | Role | What they receive |
|---|---|---|
| Hydration sensor | Experimental | The subjects use the wearable hydration sensor for ten days and undergo a dehydration/rehydration intervention on day 2 or 3. Receives: Drug: Dehydration; Dietary Supplement: Rehydration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in impedance following mild dehydration
Relative change in extracellular resistance measured by the investigational device following administration of Furosemide compared to control days
Measured: 2 hours
Secondary outcomes (1)
Change in impedance following rehydration
Relative change in extracellular resistance measured by the investigational device following ingestion of 1500 ml Resorb (Nestlé)
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start30 May 2022
- Primary completion3 Nov 2023
- Study completion3 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DehydrationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open-labeled
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mode Sensors AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Oslo University Hospital
- Responsible party
- Sponsor
- Investigators
- Sigve N Aas, PhD, Study director, Mode Sensors AS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05129358
- Sponsor's protocol ID
- CTR041 REO
- Status last verified
- Dec 2023
- First submitted
- 29 Oct 2021
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No sharing planned. Application to ethical board does not include permission to share.
Publications
Noddeland H, Bremnes F, Thorud A, Rolid K, Kvaerness J, Jaatun EA, Aas SN. A novel wearable bioimpedance sensor for continuous monitoring of fluid balance: a study on isotonic hypovolemia in healthy adults. J Clin Monit Comput. 2025 Apr;39(2):379-391. doi: 10.1007/s10877-024-01245-z. Epub 2024 Dec 4.
PubMed 39630397
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing of an Electronic Patch During Dehydration in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05129358
- Acronym / sponsor ID
- CTR041 REO
- Conditions
- Dehydration
- Keywords
- Dehydration, Rehydration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Mode Sensors ASIndustry (pharma, biotech, devices)
- Collaborators
- Oslo University Hospital
- Study start
- 30 May 2022 (actual)
- Primary completion
- 3 Nov 2023 (actual)
- Study completion
- 3 Nov 2023 (actual)
- First posted
- 22 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the ability of a wearable bioimpedance sensor to detect mild dehydration in healthy volunteers following the administration of Furosemide. In addition, the study will investigate changes in bioimpedance related to normal variation in tissue hydration (circadian changes, skin thickness, posture, and moderate activity). The study will also provide information on the durability of the sensor.
Detailed description
The subjects will use the patches for ten days. During the ten-day period, subjects are exposed to an intervention on day 2 or 3 while being monitored by health personnel:
- Subjects are given a diuretic (Furosemide) and monitored for two hours without any intake.
- The intervention is followed by intake of a rehydration solution (up to 1500 ml), containing glucose and electrolytes (Resorb Sport, Nestle S.A.).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-labeled
| Arm | Type | Receives |
|---|---|---|
| Hydration sensor | Experimental | Drug: Dehydration, Dietary Supplement: RehydrationThe subjects use the wearable hydration sensor for ten days and undergo a dehydration/rehydration intervention on day 2 or 3. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- BMI: 18-30
- Age: 18-60
- Willing to refrain from exercise for the duration of the study
- Willing to refrain from bathing, swimming and other physical activity causing considerable sweating/movement (e.g. cycling, mountain hiking, climbing)
Key exclusion criteria (9 listed)
- Hypersensitivity to diuretics
- Diarrhea
- Hypotension or orthostatic hypotension
- Urinary retention
- Pregnancy or breast feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DehydrationAlso: Dehydration from FurosemideThe subject is brought to mild dehydration (loss of approximately 1.5% of body weight) through intravenous injection of up to 40 ug Furosemide. The subject shall not ingest any fluid for the next 120 minutes. | Drug | Hydration sensor |
| RehydrationAlso: Rehydration by Resorb SportThe subject is rehydrated by oral intake of 1.5 liters Resorb Sport (Nestlé). The subject is monitored for 60 minutes following intake. | Dietary supplement | Hydration sensor |
Primary outcome
Change in impedance following mild dehydration
Time frame: 2 hours
Relative change in extracellular resistance measured by the investigational device following administration of Furosemide compared to control days
1 secondary outcome
Change in impedance following rehydration
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Derived from this study: PubMed 39630397Noddeland H, Bremnes F, Thorud A, Rolid K, Kvaerness J, Jaatun EA, Aas SN. A novel wearable bioimpedance sensor for continuous monitoring of fluid balance: a study on isotonic hypovolemia in healthy adults. J Clin Monit Comput. 2025 Apr;39(2):379-391. doi: 10.1007/s10877-024-01245-z. Epub 2024 Dec 4.
- Individual participant dataSharing planned: No. No sharing planned. Application to ethical board does not include permission to share.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sigve N Aas, PhD study director
Mode Sensors AS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dehydration and Rehydration in people with Dehydration, run by Mode Sensors AS at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in impedance following mild dehydration (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05129358, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2023.